POLICY PRODUCT VARIATIONS DESCRIPTION/BACKGROUND RATIONALE DEFINITIONS BENEFIT VARIATIONS DISCLAIMER CODING INFORMATION REFERENCES POLICY HISTORY

Transcription

1 Original Issue Date (Created): 3/1/2012 Most Recent Review Date (Revised): 9/6/2018 Effective Date: 11/1/2018 POLICY PRODUCT VARIATIONS DESCRIPTION/BACKGROUND RATIONALE DEFINITIONS BENEFIT VARIATIONS DISCLAIMER CODING INFORMATION REFERENCES POLICY HISTORY I. POLICY The use of H-wave stimulation is considered investigational for all indications, including but not limited to: treatment of pain wound healing post-operative treatment to improve function and/or range of motion There is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure. Cross-reference: MP Transcutaneous Electrical Nerve Stimulation MP Sympathetic Therapy for the Treatment of Pain MP Threshold Electrical Stimulation as a Treatment of Motor Disorders MP Interferential Current Stimulation MP Electrical Stimulation for the Treatment of Arthritis and Miscellaneous Conditions MP Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy (PNT) II. PRODUCT VARIATIONS This policy is applicable to all programs and products administered by Capital BlueCross unless otherwise indicated below. FEP PPO: The FEP program dictates that all drugs, devices or biological products approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational. Therefore, FDA-approved drugs, devices or biological products may be assessed on the basis of medical necessity. Page 1

2 III. DESCRIPTION/BACKGROUND H-wave stimulation is a form of electrical stimulation that differs from other forms of electrical stimulation, such as transcutaneous electrical nerve stimulation (TENS), in terms of its wave form. H-wave stimulation has been used for the treatment of pain related to a variety of etiologies, such as diabetic neuropathy, muscle sprains, temporomandibular joint dysfunctions or reflex sympathetic dystrophy. H-wave stimulation has also been used to accelerate healing of wounds such as diabetic ulcers and to improve range of motion and function after orthopedic surgery. H-wave electrical stimulation must be distinguished from the H-waves that are a component of electromyography. IV. RATIONALE Summary Two small controlled trials are insufficient to permit conclusions about the effectiveness of H-wave electrical stimulation as a pain treatment. Additional sham-controlled studies are needed from other investigators, preferably studies that are clearly blinded, specify the handling of any withdrawals, and provide long-term, comparative follow-up data. One small RCT represents insufficient evidence on the effectiveness of H-wave simulation for improving strength and function after rotator cuff surgery. No comparative studies have been published evaluating H-wave stimulation to accelerate wound healing. In addition, no studies were identified that evaluated H-wave stimulation for any clinical application other than those described above. Thus, H-wave electrical stimulation is considered investigational Update Review of the literature revealed no new information that would alter the conclusions reached above. Therefore, the policy statement is unchanged. V. DEFINITIONS 510 (K) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). Applicants must compare their 510(k) device to one or more similar devices currently on the U.S. market and make and support their substantial equivalency claims. Page 2

3 VI. BENEFIT VARIATIONS The existence of this medical policy does not mean that this service is a covered benefit under the member's contract. Benefit determinations should be based in all cases on the applicable contract language. Medical policies do not constitute a description of benefits. A member s individual or group customer benefits govern which services are covered, which are excluded, and which are subject to benefit limits and which require preauthorization. Members and providers should consult the member s benefit information or contact Capital BlueCross for benefit information. VII. DISCLAIMER Capital BlueCross medical policies are developed to assist in administering a member s benefits, do not constitute medical advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of members. Members should discuss any medical policy related to their coverage or condition with their provider and consult their benefit information to determine if the service is covered. If there is a discrepancy between this medical policy and a member s benefit information, the benefit information will govern. Capital BlueCross considers the information contained in this medical policy to be proprietary and it may only be disseminated as permitted by law. VIII. CODING INFORMATION Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement. Investigational; therefore, not covered: CPT Codes Current Procedural Terminology (CPT) copyrighted by American Medical Association. All Rights Reserved. HCPCS Codes E0745 G0283 Description Neuromuscular stimulator, electronic shock unit Electrical stimulation (unattended), to one or more areas for indication(s) other than wound care, as part of a therapy plan of care Page 3

4 IX. REFERENCES 1. Blum K, Chen AL, Chen TJ et al. The H-Wave device is an effective and safe nonpharmacological analgesic for chronic pain: a meta-analysis. Adv Ther 2008; 25(7): Kumar D, Marshall HJ. Diabetic peripheral neuropathy: amelioration of pain with transcutaneous electrostimulation. Diabetes Care 1997; 20(11): Kumar D, Alvaro MS, Julka IS et al. Diabetic peripheral neuropathy. Effectiveness of electrotherapy and amitriptyline for symptomatic relief. Diabetes Care 1998; 21(8): Julka IS, Alvaro M, Kumar D. Beneficial effects of electrical stimulation on neuropathic symptoms in diabetes patients. J Foot Ankle Surg 1998; 37(3): Blum K, DiNubile NA, Tekten T et al. H-Wave, a nonpharmacologic alternative for the treatment of patients with chronic soft tissue inflammation and neuropathic pain: a preliminary statistical outcome study. Adv Ther 2006; 23(3): Blum K, Chen TJ, Martinez-Pons M et al. The H-Wave small muscle fiber stimulator, a nonpharmacologic alternative for the treatment of chronic soft-tissue injury and neuropathic pain: an extended population observational study. Adv Ther 2006; 23(5): Blum K, Chen AL, Chen TJ et al. Healing enhancement of chronic venous stasis ulcers utilizing H-WAVE device therapy: a case series. Cases J 2010; 3: Blum K, Chen AL, Chen TJ et al. Repetitive H-wave device stimulation and program induces significant increases in the range of motion of post-operative rotator cuff reconstruction in a double-blinded randomized placebo controlled human study. BMC Musculoskelet Disord 2009; 10:132. X. POLICY HISTORY MP CAC 10/25/ Adopted BCBSA. Removed information regarding H-wave electrical stimulation from MP-6.020, Electrical Stimulation Modalities and created separate policy. Remains investigational for all indications. CAC 10/30/12 Consensus. No change to policy statement. References Updated. Codes reviewed 10/18/12 CAC 11/26/13 Consensus, no change to policy statements. References updated. Rationale section added. Added Medicare variation to reference NCD FEP variation changed to standard statement. Page 4

5 CAC 11/25/14 Consensus review. No changes to the policy statements. References updated. FEP variation revised to refer to the FEP policy manual. CAC 11/24/15 Consensus review. No change to policy statements. References updated. Rationale reviewed. Changed FEP variation to refer to standard investigational statement - FEP policy was archived. Coding reviewed. CAC 9/27/16 Consensus. No change to policy statements. References updated. Rationale reviewed. Variation reformatted. Coding reviewed. CAC 11/28/17 Consensus review. No change to the policy statements. References reviewed. Coding reviewed and updated. 9/06/18 Consensus review. Policy statements unchanged. Description/Background and Rationale sections updated. References reviewed. Top Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage Insurance Company, Capital Advantage Assurance Company and Keystone Health Plan Central. Independent licensees of the BlueCross BlueShield Association. Communications issued by Capital BlueCross in its capacity as administrator of programs and provider relations for all companies. Page 5